RCT using iTBS for Young People with Anorexia Nervosa: RaISE
Research type
Research Study
Full title
RaISE – Randomised Controlled Feasibility Trial of Intermittent Theta-Burst Stimulation for Young People with Anorexia Nervosa
IRAS ID
318129
Contact name
Ulrike Schmidt
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
Anorexia Nervosa (AN) is a life-threatening eating disorder characterised by an intense fear of weight gain and disturbed body image, which motivates severe dietary restriction or other weight loss behaviours (e.g., purging). Presentations of AN in children and adolescents are increasing (e.g., Agostino et al., 2021).
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses pulses of magnetic energy to stimulate areas of the brain known to contribute to psychiatric conditions. rTMS is approved by NICE (2015) as a treatment for depression and is widely used in research. We have shown that rTMS can improve eating disorder and mood symptoms in adults with AN over both the short- and long-term (Dalton et al., 2018; Dalton et al., 2020; McClelland et al., 2013a,b; Van den Eynde et al., 2010,2011). rTMS has yet to be used in adolescents with AN but could be a novel, alternative treatment for those that do not respond to the available psychological interventions. A newer form of rTMS, called Theta Burst Stimulation (TBS) applies pulses in a specific pattern, called bursts. Evidence demonstrates non-inferiority of TBS vs. rTMS, producing similar if not greater effects on brain activity with the advantage of being administered in <5 mins vs 40 mins for standard rTMS.
The aim of this feasibility RCT is to assess the uptake, retention, acceptability of 20 sessions (spread over 4 weeks) of TBS for young people with AN and to obtain treatment effect sizes for clinical outcomes at 1- and 4-months post-randomisation. Those eligible will be those aged 13-30, with a diagnosis of AN and one failed previous treatment attempt. Recruitment will be done via GP/clinician referrals from SLaM sites, the treatment will be given at the IoPPN. Participants will complete neuropsychological tests and questionnaires, and undergo fMRI scanning before and after the treatment.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
23/YH/0158
Date of REC Opinion
15 Aug 2023
REC opinion
Further Information Favourable Opinion